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This study aims to compare the effects of two commonly used topical mouth sprays on pain, swelling, and limitation of mouth opening after surgical removal of impacted lower wisdom teeth.
A total of 40 adult patients who require the removal of both lower impacted wisdom teeth will participate in this study. Each patient will undergo two separate surgical procedures, with a healing period between them. After each surgery, one of the two topical agents will be applied to the surgical area. The order of the treatments will be randomly assigned.
The study is designed so that neither the patients nor the clinician evaluating the outcomes will know which topical agent is used at each session.
Pain levels, facial swelling, and mouth opening will be measured at specific time points after surgery. The results will help determine whether one topical treatment is more effective than the other in reducing postoperative discomfort and improving recovery.
The information obtained from this study may contribute to improving postoperative care following wisdom tooth surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kloroben Topical Spray Group | Experimental | Following surgical extraction of the impacted mandibular third molar, Kloroben topical spray containing chlorhexidine gluconate and benzydamine hydrochloride is applied to the surgical site. Patients use the spray postoperatively according to the study protocol, and postoperative pain, swelling, and trismus are evaluated. |
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| Klorhex Plus Topical Spray Group | Active Comparator | Following surgical extraction of the impacted mandibular third molar, Klorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site. Patients use the spray postoperatively according to the study protocol, and postoperative pain, swelling, and trismus are evaluated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kloroben topical spray | Drug | Kloroben topical spray containing chlorhexidine gluconate and benzydamine hydrochloride is applied to the surgical site immediately after impacted mandibular third molar extraction and used postoperatively according to the study protocol to reduce pain, swelling, and trismus. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity assessed by Visual Analog Scale (VAS) | Postoperative pain intensity assessed by the Visual Analog Scale (VAS, 0-10 cm), where 0 indicates no pain and 10 indicates worst imaginable pain; higher scores indicate greater pain intensity. | From 30 minutes to 168 hours after surgery |
| Postoperative facial swelling measurements | Postoperative facial swelling measured by linear facial distances (in centimeters) including tragus to pogonion, tragus to labial commissure, and mandibular angle to lateral canthus; higher values indicate greater swelling. | Preoperatively, postoperative day 2 and postoperative day 7 |
| Maximum mouth opening (trismus assessment) | Trismus will be evaluated by measuring the maximum interincisal distance between the upper and lower central incisors using a ruler. | Preoperatively, postoperative day 2 and postoperative day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesic consumption | The number of analgesic tablets consumed by each patient will be recorded daily following surgery. | From the day of surgery to postoperative day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara Unıversity Faculty of Dentistry | Istanbul | Maltepe | 34840 | Turkey (Türkiye) |
Individual participant data will not be shared due to patient confidentiality, institutional policies, and local ethical regulations.
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This is a randomized, double-blind, crossover (split-mouth) clinical trial. Each participant undergoes two separate surgical procedures for bilateral impacted mandibular third molar extraction. After each procedure, a different topical agent is applied in a randomized order, with a healing period between interventions. Outcomes are compared within the same participant to minimize inter-individual variability.
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Monitor Clinician
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| Klorhex Plus topical spray | Drug | Klorhex Plus topical spray containing chlorhexidine gluconate and flurbiprofen is applied to the surgical site immediately after impacted mandibular third molar extraction and used postoperatively according to the study protocol to reduce pain, swelling, and trismus. |
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